International Clinical Trials Day
Contraception in Clinical Trials
The Directorate of Research and Innovation in Health (DIIS) of the Instituto Nacional de Salud has published Communication No. 001-2026-DIIS/INS, dated April 6, 2026, clarifying the criteria for compliance with the obligations established in Article 20 of the Clinical Trials Regulation (Supreme Decree No. 021-2017-SA) regarding contraception.
These clarifications are aligned with international standards such as the ICH E6 (R3)[1] Guideline for Good Clinical Practice and the recommendations of the Clinical Trials Coordination Group (CTCG)[2] of the European Union.
The communication establishes the following:
1. What is understood by a woman of childbearing potential?
- The criterion is biological capacity, not chronological age.
- Any woman from menarche to postmenopause is considered fertile, unless she has permanent sterility.
2. Which contraceptive methods qualify as highly effective?
- In accordance with the ICH M3 (R2) Guideline and the recommendations of the CTCG, these are methods with a failure rate of less than 1% per year when used correctly and consistently.
- Accepted methods include: hormonal methods that inhibit ovulation; IUDs/IUSs; surgical sterilization; confirmed vasectomy of the male partner (documented azoospermia); and sexual abstinence, solely when it is continuous and consistent with the participant’s usual lifestyle.
- These methods are required in all clinical trials where there is a potential risk to the embryo or fetus.
3. Who assumes responsibility and bears the cost?
- Article 20 of the Regulation establishes that the sponsor and the investigator must guarantee counseling and access to contraceptive methods at no cost to the research subject.
- The method must be freely chosen by the participant, be compatible with the conditions of the clinical trial, and be included in both the protocol and the informed consent form.
- The communication clarifies that “participants and their health insurance providers, whether public or private, are not responsible for assuming the provision or financing of such methods, as this responsibility lies with the sponsor during the period established in the protocol.”
4. What must the principal investigator verify and document?
- Verify, throughout the entire protocol period, the contraceptive method used and the participant’s commitment to preventing conception.
- The information documented in the source records must include date, signature, and traceability.
- In the event of any change in contraceptive method, including the discontinuation of sexual abstinence, an accepted method under the protocol must be immediately indicated and documented before sexual activity is resumed.